Personalised neoadjuvant therapy planning for adults with high‑risk soft tissue sarcoma
Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
This project tests whether analyzing tumor tissue and clinical data can help guide neoadjuvant chemotherapy decisions for adults with high‑risk soft tissue sarcomas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT07432932 on ClinicalTrials.gov |
What this trial studies
This multi‑centre cohort project collects both retrospective and prospective tumor tissue and clinical data from adults with high‑risk soft tissue sarcomas, including dedifferentiated liposarcoma, leiomyosarcoma, synovial sarcoma, vascular sarcomas and MPNST. Patients are enrolled in two cohorts: those who proceed directly to surgery and those who receive neoadjuvant chemotherapy followed by surgery. Pseudonymised samples and data are shared under HTA‑compliant agreements and analyzed at dedicated translational laboratories to identify biomarkers associated with chemotherapy response. The collaboration across five European sarcoma centres aims to increase sample size and enable comparative, stratified analyses to inform personalised neoadjuvant approaches.
Who should consider this trial
Good fit: Adults (≥18) with resectable, measurable high‑risk soft tissue sarcoma (≥5 cm or grade 3 or deep location) of subtypes such as DDLPS, LMS, SS, vascular sarcomas or MPNST who are fit for biopsy and surgical resection and able to give informed consent, and who are medically fit for neoadjuvant chemotherapy if enrolled in that cohort.
Not a fit: Patients with low‑risk or unresectable sarcomas, those unable to provide required tissue or consent, or those whose immediate clinical care would not be influenced by translational findings are unlikely to derive direct benefit from this observational program.
Why it matters
Potential benefit: If successful, this approach could help match high‑risk sarcoma patients to neoadjuvant chemotherapy more accurately, avoiding unnecessary treatment for some and improving outcomes for likely responders.
How similar studies have performed: Biomarker‑driven neoadjuvant strategies have shown promise in other cancers and small sarcoma series, but robust multi‑centre prospective evidence in high‑risk STS is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Written informed consent for the prospective cohort
* Histopathological diagnosis of high-risk soft tissue sarcoma and one of the following subtypes: DDLPS, LMS, SS, vascular sarcomas or MPNST. Other subtypes may be included with PI approval.
* High-risk sarcoma definition:
* Greater than 5cm or Grade 3
* Deep anatomic location
* Have disease amenable to biopsy
o Patients who are not amenable to repeat biopsy at baseline can be reviewed with the local site PI for consideration of inclusion to the study
* Resectable tumour
* Measurable disease by RECIST 1.1
* Aged ≥ 18 years
* WHO performance status 0-2
* For patients receiving NCT, medically fit enough, with adequate organ function, to undergo neoadjuvant chemotherapy
* Patients medically fit enough to undergo surgical resection
* Capable of giving written informed consent (for prospective cohort) and comply with the study schedule
* Patients may also participate in the STRASS 2 trial
Exclusion Criteria:
-Prior invasive malignancy in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI.
* Known additional malignancy that is progressing or requires active treatment
* Metastatic disease not amenable to curative intent local therapy
* Any active uncontrolled medical conditions
Where this trial is running
London
- The Royal Marsden Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Stephanie Elston, MSc
- Email: PANTHRS.Trial@rmh.nhs.uk
- Phone: 02073528171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.